Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

In accordance with REACH Annex XI it is considered appropriate to omit the Screening for reproductive/developmental toxicity study due to the substance's apparent lack of bioavailability and thus testing does not appear scientifically necessary. The substance displayed no signs of toxicity in acute toxicity tests via the oral route at levels of 5000mg/kg bw or the inhalation route at the highest achievable concentration and has been shown to be unreactive, insoluble in the various texts conducted and there is no evidence of toxicity in a 28 day "limit test" via the oral route.

Link to relevant study records
Reference
Endpoint:
toxicity to reproduction
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Reproductive effects observed:
not specified
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information
In accordance with REACH Annex XI it is considered appropriate to omit the Screening for reproductive/developmental toxicity study due to the substance's apparent lack of bioavailability and thus testing does not appear scientifically necessary.  The substance displayed no signs of toxicity in acute toxicity tests via the oral route at levels of 5000mg/kg bw or the inhalation route at the highest achievable concentration and has been shown to be unreactive, insoluble in the various texts conducted and there is no evidence of toxicity in a 28 day "limit test" via the oral route.
Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Abnormalities:
not specified
Developmental effects observed:
not specified
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification